Total Knee Replacement — Class II medical device recall Z-0600-2018
Terminated recall by ConforMIS, Inc., reported 2018-02-21, distributed in CA, TX. Implant kit mislabeled
| Recall number | Z-0600-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2017-07-24 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-02-01 |
| Distributed | CA, TX |
| Quantity | 2 units |
| Reason classes | labeling |
| Serial numbers | 0398482, 0399917 |
| Model numbers | TPS-111-1111 |
| Expiration dates | 2017-12-31 |
Product
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Reason for recall
Implant kit mislabeled
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0600-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.